Childrens Motrin

Product NDC
50580-184
11-digit product format
505800184
Labeler code
50580
Product ID
50580-184_21d440bd-8a6a-5109-e063-6394a90a0e8f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020516
Marketing category
NDA
Marketing start
2001-09-01
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50580-18450580-184-51DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020516-001CHILDREN'S MOTRINIBUPROFEN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts mo...

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Motrin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803, 544393

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-184-01Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-01Childrens Motrin240 mL in 1 BOTTLE, PLASTICSUSPENSION24016
50580-184-50Childrens Motrin120 mL in 1 BOTTLE, PLASTICSUSPENSION12016
50580-184-50Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-51Childrens Motrin2 in 1 PACKAGESUSPENSION216
50580-184-51Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-52Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-52Childrens Motrin3 in 1 PACKAGESUSPENSION316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-184-01ML - Milliliter50580-184caaf1f42-8d81-4ba5-881b-9388970c167f12024-04-05
50580-184-04ML - Milliliter50580-184ffebdb3b-7bbe-4eb8-9c01-a2d86a8a610812012-07-24
50580-184-50ML - Milliliter50580-18472ff8340-92b0-45d3-9bdf-86e42ec9772612014-06-03
50580-184-51ML - Milliliter50580-18485e8878f-8320-4267-8558-e42651140b3f12021-08-05
50580-184-52ML - Milliliter50580-1847da964f5-ec53-4b7a-b389-5df2eaa7bf4b12021-09-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-184CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 8 package rows20241103_9e1cdef7-921f-4163-869c-6c062e31c5bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Motrin Children 100 MG in 5 mL Oral SuspensionPSN9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393ibuprofen 20 MG/ML Oral Suspension [Motrin]SBD9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 20 MG/ML Oral SuspensionSCD9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Children's Motrin 100 MG per 5 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Motrin 20 MG/ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-184-01505800184011 BOTTLE, PLASTIC in 1 CARTON (50580-184-01) / 240 mL in 1 BOTTLE, PLASTIC2021-12-270000-00-00NoNoCurrent
50580-184-50505800184501 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) / 120 mL in 1 BOTTLE, PLASTIC2012-02-280000-00-00NoNoCurrent
50580-184-51505800184512 CARTON in 1 PACKAGE (50580-184-51) > 1 BOTTLE, PLASTIC in 1 CARTON > 120 mL in 1 BOTTLE, PLASTIC2 carton2019-02-040000-00-00NoNoCurrent
50580-184-52505800184523 CARTON in 1 PACKAGE (50580-184-52) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC3 carton2021-05-030000-00-00NoNoCurrent